CompletedNCT00696449Updated Sep 10, 2018Results posted

Analysis of Adherence in Subjects Undergoing Differin Gel, 0.1% Treatment of Moderate to Severe Acne Vulgaris

A Phase 4 interventional study of Adapalene and frequent visits in Acne Vulgaris, sponsored by Wake Forest University. Completed at 1 site in United States. Open to participants aged 13 Years to 18 Years. Per ClinicalTrials.gov, last updated 2018-09-10.

Sponsored by Wake Forest University · Phase 4, Interventional, and Treatment

Phase: Phase 4
Study type: Interventional
Enrollment: 61
Allocation: Randomized
Ages: 13 Years to 18 Years
Sex: All

Study summary

The primary objective of this study is to investigate potential differences between four treatment intervention groups in the adherence to treatment with Differin® Gel, 0.1%. Differin is approved by the Food and Drug Administration (FDA) to treat acne.

Read the detailed description

Subjects will be enrolled and randomized in a 1:1:1:1 ratio to one of four treatment intervention groups. All Subjects will be treated once-daily for 12 weeks with Differin® Gel, 0.1%. The four intervention groups were designated according to follow-up strategies as follows:

More frequent than normal office visits
Electronic reminders (voice, e-mail, text messages)
Parental involvement/intervention reminders
No intervention or reminders

Conditions studied

Acne Vulgaris

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Acne Vulgaris 750

In context

Acne Vulgaris

750 studies on the registry are indexed under Acne Vulgaris; 89 are open to participants now.

This study's enrollment of 61 is below the median of 69 across 647 interventional studies indexed under Acne Vulgaris.

Browse Acne Vulgaris studies →

Lead sponsor

Wake Forest University is the lead sponsor of 118 studies on the registry; 7 are open to participants now.

Of its 31 completed or terminated interventional studies of FDA-regulated products, 27 (87%) have results posted.

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Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 13 Years to 18 Years
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Male or female Subjects of any race, aged 13 to 18 years inclusive,
Subjects with a diagnosis of moderate to severe Acne vulgaris, measured by lesion counts of a minimum of 15 and a maximum of 50 inflammatory lesions (papules and pustules) on the face, AND a minimum of 30 and a maximum of 125 total lesions. Subjects with nodules may participate in the study.
Female Subjects of childbearing potential must have a negative urine pregnancy test (UPT).
Female Subjects of childbearing potential must practice a highly effective method of contraception during the study
Subjects (and parent/guardian if Subject is under 18 years of age) must be willing and capable of following study instructions to the extent and degree required by the protocol;
Subjects able to follow study instructions and likely to complete all required visits;
Subjects/Representative signs the Informed Consent prior to any study procedures. Subjects under the age of 18 must have one parent or guardian read and sign the Informed Assent Form prior to receiving study treatment but the parent(s) or guardian is not required to attend the follow-up visits unless requested;
Subject must be willing to be photographed and sign a release form allowing photographs to be used.

Exclusion criteria

Exclusion Criteria:

Female Subjects who are pregnant, nursing or planning a pregnancy during the study,
Subjects with a condition or who are in a situation which, in the Investigator's opinion, may put the Subject at risk, may confound the study results, or may interfere with the Subject's participation in the study,
Subjects with known allergy to one of the components of the test products,
Subjects who have participated in another investigational drug or device research study within 30 days of enrolment, Subjects with acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.), or or severe acne requiring more than topical treatment (e.g. oral isotretinoin);
Subjects with a beard or other facial hair that might interfere with study assessments;
Subjects with underlying diseases or other dermatological conditions that require the use of interfering topical or systemic therapy such as, but not limited to, atopic dermatitis, perioral dermatitis or rosacea;
Subjects who are at risk in terms of precautions, warnings, and contra-indication (see package insert for Differin Gel, 0.1%);
Subjects who foresee intensive UV exposure during the study (mountain sports, UV radiation, sunbathing, etc.);
Subjects with a known history of drug and/or alcohol abuse.

Study design

Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Single (Investigator)
Enrollment: 61 participants (actual)

Study arms

Experimental
Frequent visits
This group will be asked to return to the study center on weeks 1, 2, 4 and 8 for office visits (to remind the Subject to apply the study medication); in addition to the study visits on Weeks 6 and 12.
Drug: Adapalene · Behavioral: frequent visits
Experimental
Electronic reminder
This group will receive a daily electronic reminder by email, text pager, or phone message (approximately at the same time each day) to use the study medication within a 4-hour window after the reminder and will return to the study center for study visits on Weeks 6 and 12.
Drug: Adapalene · Behavioral: electronic reminder
Experimental
Parent reminder
In this group parents will be prompted by a daily electronic message by email, text pager, or phone message (approximately at the same time each day) to remind the Subject to use the study medication within a 4-hour window after the reminder. Parents will be instructed to then verbally deliver the message to the study Subject. Subjects will return to the study center for study visits on Weeks 6 and 12.
Drug: Adapalene · Behavioral: Parent reminder
Experimental
Standard of care
This group is considered to be the "standard of care" arm and will return to the study center for study visits on Weeks 6 and 12. This group will not receive any kind of reminders other than the instructions provided by the study staff during the study visits.
Drug: Adapalene · Behavioral: Standard of care

Interventions

DrugAdapalene
All Subjects will treat the face once daily in the evening.
Also known as: Differin® Gel, 0.1%
Behavioralfrequent visits
This group will be asked to return to the study center on weeks 1, 2, 4 and 8 for office visits (to remind the Subject to apply the study medication); in addition to the study visits on Weeks 6 and 12.
Behavioralelectronic reminder
This group will receive a daily electronic reminder by email, text pager, or phone message (approximately at the same time each day) to use the study medication within a 4-hour window after the reminder and will return to the study center for study visits on Weeks 6 and 12.
BehavioralParent reminder
In this group parents will be prompted by a daily electronic message by email, text pager, or phone message (approximately at the same time each day) to remind the Subject to use the study medication within a 4-hour window after the reminder. Parents will be instructed to then verbally deliver the message to the study Subject. Subjects will return to the study center for study visits on Weeks 6 and 12.
BehavioralStandard of care
This group is considered to be the "standard of care" arm and will return to the study center for study visits on Weeks 6 and 12. This group will not receive any kind of reminders other than the instructions provided by the study staff during the study visits.

What researchers measure

Primary outcomes

Adherence to Treatment
Percentage of prescribed doses taken over the 12-week study period, as measured by a Medication Event Monitoring System (MEMS) cap
Time frame: 12 weeks

Results

Posted Mar 30, 2017

Participant flow

Participant flow — Overall Study
Milestone	Frequent Office Visits	Electronic Reminders	Parental Reminders	Standard of Care Control
Started	15	15	15	16
Completed	12	9	14	13
Not completed	3	6	1	3

Outcome measures

PrimaryAdherence to Treatment

Percentage of prescribed doses taken over the 12-week study period, as measured by a Medication Event Monitoring System (MEMS) cap

Time frame:: 12 weeks
Reported as:: Median · Percent of prescribed doses

Adherence to Treatment
Percent of prescribed doses	Frequent Office Visits	Electronic Reminders	Parental Reminders	Standard of Care Control
Adherence to Treatment	64 (10 to 98)	38 (0 to 98)	28 (5 to 60)	52 (2 to 83)

Adverse events

Non-serious events are listed at a 1% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Frequent Office Visits	—	0/15 (0%)	0/15 (0%)
Electronic Reminders	—	0/15 (0%)	0/15 (0%)
Parental Reminders	—	0/15 (0%)	0/15 (0%)
Standard of Care Control	—	0/16 (0%)	0/16 (0%)

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	Frequent Office Visits	Electronic Reminders	Parental Reminders	Standard of Care Control	Total
<=18 years	15	15	15	16	61
Between 18 and 65 years	0	0	0	0	0
>=65 years	0	0	0	0	0

Sex: Female, Male
Sex: Female, Male(Participants)	Frequent Office Visits	Electronic Reminders	Parental Reminders	Standard of Care Control	Total
Female	7	8	9	10	34
Male	8	7	6	6	27

Region of Enrollment
Region of Enrollment(participants)	Frequent Office Visits	Electronic Reminders	Parental Reminders	Standard of Care Control	Total
United States	15	15	15	16	61

Study locations

1 site

Wake Forest University Health Sciences Dermatology
Winston-Salem, North Carolina 27157, United States

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Timeline

Tracking since Sep 25, 2026

Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jun 2006, a primary completion of May 2007 and a completion of Oct 2009. It does not say whether these dates are actual or estimated.

Results were first posted in Mar 2017, 9 years 10 months after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered: Jun 9, 2008
First posted: Jun 12, 2008
Start: Jun 2006
Primary completionActual: May 2007
CompletionActual: Oct 2009
Results first posted: Mar 30, 2017
Last update: Sep 10, 2018

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Sep 10, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00696449
Lead sponsor: Wake Forest University
Responsible party: Sponsor
First posted: Jun 12, 2008
Start date: Jun 2006
Primary completion: May 2007
Completion: Oct 2009
Results posted: Mar 30, 2017
Last update: Sep 10, 2018

Study contacts

Steve Feldman, MD, PhD

principal investigator · Wake Forest University Health Sciences

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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